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GUIDANCE DOCUMENT

Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment Draft Guidance for Industry September 2021

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0544


Docket Number:
FDA-2021-D-0544
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC).

Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding clinical trial design issues, choice of study population, and endpoints for the treatment of naïve and refractory NTM-PD caused by MAC. The design of clinical trials of new drugs for the treatment of NTM-PD was discussed during an FDA public workshop.

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